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Supreme Court of India

THE DRUGS INSPECTOR AND ANR.versusM/S. FIZIKEM LABORATORIES PVT. LTD. AND ANR.

Citation
2008 INSC 393
Decided
24 March 2008
Disposal
Case Allowed

Holding

An inspector appointed under Chapter IV of the Drugs and Cosmetics Act is competent to launch prosecution for misbranding, adulteration, or spurious offences even when an Ayurvedic product contains an allopathic drug without the requisite licence.

Summary

The Drugs Inspector seized samples of Ozomen capsules and Ozomen forte, which were found to contain sildenafil citrate, an allopathic drug, in quantities ranging from 33.9 mg to 46.8 mg per capsule. The respondents, who held licences for Ayurvedic and allopathic medicines but not for manufacturing sildenafil citrate, were prosecuted under Sections 18(c), 18(a)(i) read with Section 17B(d) of the Drugs and Cosmetics Act for manufacturing and selling a misbranded, spurious, and adulterated drug. The High Court quashed the prosecution, holding that only an inspector appointed under Chapter IVA (which deals with Ayurvedic, Siddha and Unani drugs) could initiate proceedings for such offences. On appeal, the Supreme Court observed that the provisions of Chapter IV and Chapter IVA are virtually identical and that the use of an allopathic drug in an Ayurvedic preparation without proper labeling and licence falls within the ambit of Chapter IV offences. Consequently, the Court held that an inspector appointed under Chapter IV is competent to prosecute the respondents, and set aside the High Court’s order. The appeal was allowed, and the prosecution under Chapter IV was directed to proceed.

Issues considered

  • The jurisdiction of a Drugs Inspector appointed under Chapter IV of the Drugs and Cosmetics Act to prosecute offences involving misbranding, adulteration, or spurious nature of an Ayurvedic drug containing an allopathic ingredient.
  • Whether the presence of sildenafil citrate, an allopathic drug, in an Ayurvedic preparation makes the product fall exclusively under Chapter IVA or also within the scope of Chapter IV.
  • Whether the respondents, lacking a licence to manufacture sildenafil citrate, can be prosecuted under Sections 18 and 27 of the Act.

Legislation cited

Subjects

Drugs and Cosmetics ActmisbrandingadulterationAyurvedic drugsAllopathic drugsildenafil citratelicensingjurisdiction of inspectorSection 18Section 27Section 482criminal prosecution

Judgment

                         [2008] 5 S.C.R. 465


               THE DRUGS INSPECTOR AND ANR.                         A
                                  v
       MIS. FIZIKEM LABORATORIES PVT. LTD. AND ANR.
                (Criminal Appeal No. 533 of 2008)
                         MARCH 24, 2008
                                                                    B
           [A.K. MATHUR AND ALTAMAS KABIR, JJ.]

         Drugs and Cosmetics Act, 1940: ss.18, 19 rw s.17B(d),
    s.27(b)(fi) -Adulteration and misbranding in Ayurvedic drugs
    - Ozomen capsules and Ozomen forte containing 55.2 mg of c
    sildenafil citrate per capsule - Accused holding allopathic and
    Ayurvedic licence but not holding licence to manufacture
    sildenafil citrate - Prosecution launched under Chapter IV -
    High Court quashed proceeding holding that since ozomen
    capsule had component like sildenafil citrate, therefore, they
                                                                     D
)   are misbranded, spurious or adulterated for which prosecution
    could be only launched under Chapter /VA- Correctness of-
    Held: Not correct - Inspector appointed under Chapter IV is
    competent to launch prosecution under said sections -
    Sildenafil citrate is an Allopathic drug - It cannot be used for
    the Ayurvedic medicines without displaying in prescribed E
    manner on the label or container thereof or list of active
    ingredients contained in it together with the quantities thereof
    - A/so it cannot be used by person not holding licence for it -
    Code of Criminal Procedure, 1973 - s.482.
                                                                     F
         The prosecution case was that the Inspector of Drug
    took samples of ozomen capsules and ozomen forte from
    the premises of respondent-accused and sent it for
    analysis. According to the report of Government Analyst,
    Ozomen capsules under different batches contained 45.2
                                                                     G
    mg of sildenafil citrate per capsule. Prosecution was
    launched against the respondents for contravention of
    ss.18(c), 18(a) (i) read with s.17B(d) of the Drugs and
    Cosmetics Act.
                                 465                                H
    466      SUPREME COURT REPORTS                 [2008] 5 S.C.R.


A       The allegation of prosecution was that the sildenafil
  citrate is an allopathic drug used for erectile dysfunction;
  that accused had no licence for the manufacture of
  sildenafil citrate and they were mislabeling the Ayurvedic
  drugs; and that the respondent-accused company was
B holding Allopathic as well as Ayurvedic licence but the
  company did not hold the licence to manufacture
  sildenafil citrate.
       The respondent's contention was that they had been
  holding licence for the Ayurvedic preparation and for any
C Ayurvedic preparation of spurious or misbranded nature,
  Inspector appointed under Chapter IV was not competent
  to launch prosecution.
        High Court quashed the proceedings holding that
  since Ozomen capsules had a component like sildenafil
D citrate, therefore, they may be misbranded, spurious or
  adulterated for which the prosecution could only be
  launched by the Inspector authorised under Chapter IVA.
  But the prosecution in this case was launched under
  Chapter IV and the Inspector who has been appointed
E under Chapter IVA could have launched the prosecution.
  Hence the present appeal.
          Allowing the appeal, the Court
         HELD: 1. The provisions in Chapter IV and Chapter
F   IVA of the Drugs and Cosmetics Act are almost identical.
    Chapter IVA deals with special branch of medicines like,
    Ayurvedic, Siddha and Unani drugs whereas Chapter IV
    deals with branches other than Chapter IVA. [Para 6]
    [475-A]
G      2. Sildenafil citrate is a new drug and it is an Allopathic
  drug. This cannot be used for the Ayurvedic medicines
  without displaying in the prescribed manner on the label
  or container thereof or list of active ingredients contained
  in it together with the quantities thereof. It is also
H punishable under s.18 (a)(iii) read with s.27 (d) of the Act.
THE DRUGS INSPECTOR AND ANR. v. M/S. FIZIKEM                467
       LABORATORIES PVT. LTD. & ANR.

The very fact of dealing with sildenafil citrate drug and A
                                       a
distributing the same after making different component
of Ayurvedic drug itself constitutes an offence. It is
erroneous to say that since the accused is dealing with
Ayurvedic drugs therefore, only the Inspector who is
authorized under Chapter IVA could launch the B
prosecution and not the Inspector appointed under r '
Chapter IV. The accused has used sildenafil citrate which
is an allopathic drug. Sildenafil citrate is a white to off.
white crystalline power with a solubility of 3.5 mg/ml in
water and molecular weight of 666.7. Viagra (sildenafil            c
citrate) is formulated as blue, film-coated rounded-
diamond shaped tablets equivalent to 25mg, 50 mg and
100 mg of sidenafil for oral administration. In addition to
the active ingredient, sildenafil citrate, each tablet contains
the following inactive ingredients; microcrystalline
                                                                0
cellulose, anhydrous dibasic calcium· phosphate,
croscarmellose sodium, magnesium stearate,
hypromellose, titanium dioxide Lactose, triacetin and FD
and C Blue No.2 aluminum lake. The brand name is Viagra
and generic name is sildenafil citrate. This is an allopathic
drug and by no stretch of imagination it can be said as an· E
Ayurvedic drug. Therefore, it is correct to say that since it
is an allopathic drug and it cannot be used by anybody
else unless a person who holds the licence for it. It is an
admitted position that the accused does not possess the
licence. Therefore, the very fact of selling this d;ug as one F
of the ingredients in the Ozomen capsule and not
displaying the name in the prescribed manner in the
drugs will also constitute an offence under s.18 (a), (b) &
(c) punishable under s.27(b) (ii). [Para 7] [475-G & H; 476-
B, C, D, E, F & G]                                              G
    CRIMINAL APPELLATE JURISDICTION : Criminal
Appeal No. 533 of 2008.

     From the final Order dated 17.4.2006 of the High Court of
Judicature, Andhra Pra'<:Jesh at Hyderabad in Crl. P. Nos. 4475,   H
    468       SUPREME COURT REPORTS                    [2008] 5 S.C.R.


A   4476,4477,4479,4480,4481,4482,4565,4566,4567,4568,
    4569, 4570, 4571, 4572, 4573, 4574/2005 and 942, 943, 944,
    946, 947 and 948/2006.

          Anoop G. Choudhari, June Choudhari, D. Bharathi Reddy,
    Altaf Fatima and Debojit Barkakoti for the Appellants.
B
         Sidharth Luthra, Sanjeev Sachdeva, Rajni Gupta and Shri
                                                                              t
    Singh for the Respondents.

          The Judgment of the Court was delivered by

c         A.K. MATHUR, J. 1. Leave granted.

        2. This appeal is directed against the order passed by
  learned Single Judge of the Andhra Pradesh High Court in a
  batch of petitions under Section 482 of the Code of Criminal
  Procedure (hereinafter to be referred to as "the CrPC") whereby
D the learned Single Judge has held that the Drugs Inspector
  appointed under Section 21 of the Drugs and Cosmetics Act,              .,
                                                                          .

  1940 (hereinafter to be referred to as "the Act") had no jurisdiction
  to launch prosecution under Section 32 of the Act for alleged
  offences said to have been committed under this Act in
E connection   with manufacture and sale of Ayurvedic drugs
  Ozomen capsules and Ozomen forte.
        3. The brief facts which are necessary for disposal of this
  appeal are that the Inspector of Drugs inspected some of the
  business premises of these respondents where Ozomen
F capsules and Ozomen forte were available for sale. He took
  the samples and after taking the sample he sent the same to
  the Government Analyst, Hyderabad for analysis. The
  Government Analyst submitted his report declaring that Ozomen
  capsules under different batches contained 45.2 mg of sildenafil
G citrate per capsule. The persons from whom the samples were
  taken were called upon to disclose the name of manufacturer
  and on disclosure of the name of manufacturer, prosecution was
  launched against the respondents for contravention of Sections              .
  18(c), 18(a) (i) read with Section 17B(d) of the Act namely,
H prohibition of manufacture and sale of certain drugs and
       THE DRUGS INSPECTOR AND ANR. v. M/S. FIZIKEM                469
       LABORATORIES PVT. LTD. & ANR. (A.K. MATHUR, J.]

       cosmetics which are misbranded, spurious and substituted A
       wholly or in part by another drug or substance and the Central
       Government prohibited manufacturer etc. of the drugs and
       cosmetics in public interest under notification issued under
       Section 26-A, vide notification No.GSR 577(e) dated 23.7.1983
       punishable under Sections 27(b)(ii), 27(c), 27(d) and 28-B of B
       the Act. It is this action initiated by the Drugs Inspector which
-}
       was challenged. The respondents were arrayed as accused for
       the aforesaid offences because they had no licence for the
       manufacture of Ayurvedic drug sildenafil citrate and they were
       mislabeling the Ayurvedic drugs. The sildenafil citrate is a new   c
       drug and it is patent and proprietary medicine. It is an allopathic
       drug used for erectile dysfunction. The respondent-accused
       company was holding Allopathic as well as Ayurvedic licence
       but the company does not hold the licence to manufacture
       sildenafil citrate. The information was received by the Drugs
                                                                           D
       Inspector that sildenafil citrate manufactured by these companies
       for various medical establishments in the State of Andhra
       Pradesh had no licence to manufacture sildenafil citrate.
       Ozomen forte capsule contained 33.9 mg to 46.82 mg of
       sildenafil citrate per capsule. Therefore, the question was
       whether the respondent- company which are manufacturing E
       Ayurvedic drug and had no licence for manufacturing sildanefil
       forte could be prosecuted under Chapter IV or not.

            4. Before the Learned Single Judge it was submitted that
       since the respondents are being prosec\.]ted for contravention F
       of Section 18, Section 19(a) (i) read with section 178 (d) and
       Section 17(b) of the Act the accused had no licenc.e for
       manufacture of the sildenafil forte which is one of ingredient of
       Ozomen forte i.e. Ayurvedic drug, therefore, the respondent can
       be prosecuted under this section or not. The submission of the
                                                                         G
       respondents was that they have been holding licence for the
       Ayurvedic preparation and for any Ayurvedic preparation of
       spurious or misbranded nature, the Inspector appointed under
....
       Chapter IVA alone is competent to launch prosecution and not
       Inspector appointed under Chapter IV.
                                                                         H
    470          SUPREME COURT REPORTS                  [2008] 5 S.C.R.


A        5. In order to appreciate the contention raised by learned
    counsel for the parties, it will be appropriate to refer to relevant
    provisions of the Act. The Act defines Ayurvedic Siddha or Unani
    drug under Section 3(a) which reads as under:
          "(a) "Ayurvedic, Siddha or Unani drug" includes all
B         medicines intended for internal or external use for or in the
          diagnosis, treatment, mitigation or prevention of disease
          or disorder in human beings or animals, and manufactured
          exclusively in accordance with the formulae described in,
          the authoritative books of Ayurvedic, Siddha and Unani
c         Tibb system of medicine, specified in the First Schedule;"

          Section 3(e) defines Inspector which reads as under:
          " (e) "Inspector" means -
          (i)    in relation to Ayurvedic, Siddha or Unani drug, an
D
                 Inspector appointed by the Central Government or a
                 State Government under section 33G; and
          (ii)   in relation to any other drug or cosmetic, an Inspector
                 appointed by the Central Government or a State
E                Government under section 21 ;"
         Section 3(h) defines patent and proprietary medicine
    which reads as under:
          "(h) "patent or proprietary medicine" means,-
F         (i)    in relation to Ayurvedic, Siddhi:i or Unani Tibb
                 systems of medicine all formulations containing only
                 such ingredients mentioned in the formulae
                 described in the authoritative books of Ayurveda,
                 Siddha or Unani Tibb systems of medicine specified
G                in the First Schedule, but does not include a medicine
                 which is administered by parenteral route and also
                 a formulation included in the authoritative books as
                 specified in clause (a);
          (ii)   in relation to any other systems of medicine, a drug
H
     THE DRUGS INSPECTOR AND ANR. v. M/S. FIZIKEM                      471
     LABORATORIES PVT. LTD. & ANR. [A.K. MATHUR, J.]

                which is a remedy or prescription presented in a               A
                form ready for internal or external administ~ation of
                human beings or animals and which is not included
                in the edition of the Indian Pharmacopoeia for the
                time being or any other Pharmacopoeia authorized
                in this behalf by the Central Government after                 B
                consultationwith the Drugs Technical Advisory Board
                constituted under section 5;"
           Section 13 deals with offences. Chapter IV deals with
     Manufacture, sale and distribution of drugs and cosmetics.
     Section 16 under this Chapter deals with standard and quality. C
     As per Section 16, all drugs complies with the standard set out
     in the second schedule. Section 17 deals with misbranded drugs
     which reads as under:
          "17. Misbranded drugs.- For the purposes of this Chapter
                                                                   0
~         a drug shall be deemed to be misbranded,-
          (a)   if it is so coloured, coated, powered or polished that
                damage is concealed or if it is made to appear or
                better or greater therapeutic value than it really is; or
          (b)   if itis not labeled in the prescribed manner; or               E

          (c)   if it is label or container or anything accompanying
                the drug bears any statement, design or device which
                makes any false claim for the drug or which is false
                or misleading in any particular.                               F
>+      . Section 17A deals with adulterated drugs which reads as
     under:
          "17A. Adulterated drugs- For the purposes of this Chapter,
          a drug shall be deemed to be adulterated,-                           G
          (a)   if it consists in whole or in part, of any filthy, putrid or
                decomposed substance; or
          (b)   if it has been prepared, packed or stored under
                insanitary conditions whereby it may have been                 H
    472          SUPREME COURT REPORTS                    [2008] 5 S.C.R.


A                 contaminated with filth or whereby it may have been
                  rendered injurious to health; or
          {c)     if its container is composed, in whole or in part, of
                  any poisonous or deleterious substance which may
                  render the contents injuriou.s to health; or
B
          {d)     if it bears or contains, for purposes of colouring only,   +
                  a colour other·than one which is pr~scribed; or

          (e)    if it contains any harmful or toxic substance which
                 may render it injurious to health; or
c
          (f)    if any substance has been mixed therewith so as to
                 reduce its quality or strength."
        Section 178 deals whh spurious drugs, Section 17C deals
  with misbranded cosmetics and Section 170 deals with
D spurious cosmetics. Section 18 which deals with prohibition of
  manufacture and sale of certain drugs and cosmetics, is relevant
  for our purpose and reads as under :
          " 18. Prohibition of manufacture and sale of certain drugs
          and cosmetics. From such date as may be fixed by the
E
          State Government by notification in the Official Gazette in
          this behalf, no person shall himself or by any other person
          on his behalf-
          (a)    manufacture for sale or for distribution, or sell, or
F                stock or exhibit or offer for sale, or distribute-
          (i)     any drug which is not of a standard quality, or is
                 .misbranded, adulterated or spurious;
          (ii)   any cosmetic which is not of a standard quality or is
G                misbranded or spurious;
          (iii) any patent or proprietary medicine, unless there is.
                displayed in the prescribed manner on the label or
                contaiher thereof the true formula or list of active
                ingred'ents contained in it together with the quantities,
H               thereof;
             THE DRUGS INSPECTOR AND ANR. v. MIS. FIZIKEM                     473
             LABORATORIES PVT. LTD. &.ANR. [A.K. MATHUR, J.]

        4         (iv)   any drug which by means of any statement, design             A
                         or device accompanying it or by any other means,
i
    ~                    purports or claims to prevent, cure or mitigate any
                         such disease or ailment, or to have any such other
                         effect as may be prescribed;

                         any cosmetic containing any ingredient which may             B
                  (v)
        ~t               render it unsafe or harmful for use under the directions
                         indicated or recommended;

                  (vi)   any drug or cosmetic in contravention of any of the
                         provisions of this Chapter or any rule made                  c
                         thereunder;

                  (b)    sell, or stock or exhibit or offer for sale, or distribute
                         any drug or cosmetic which has been imported or
                         manufactured in contravention of any of the provisions
                         of this Act or any rule made thereunder;                     D·

         '        (c)    manufacture for sale or for distribution, or sell, or
                         stock or exhibit or offer for sale, or distribute any
                         drug or cosmetic, except under, and in accordance
                         with the conditions of, a licence issued for such
                                                                                      E
                         purpose under this Chapter;
                  Provided that nothing in this section shall apply to the
                  manufacture, subject to prescribed conditions, of small
                  quantities of any drug for the purpose of examination, test
                  or analysis;                                                        F
                  Provided further that the Central Government may, after
                  consultation with the Board, by notification in the Official
                  Gazette, permit, subject to any conditions specified in the
                  notification, the manufacture for sale or for distribution,
                  sale, stocking or exhibiting or offering for sale or G
                  distribution of any drug or class of drugs not being of
                  standard quality."
         ~
                  Section 18 prohibits any person from manufacturing for
             sale or for distribution or sell or stock or exhibit or offer for sale
                                                                                      H
    474       SUPREME COURT REPORTS                    (2008] 5 S.C.R.


A or distribute any drug which is not of a standard quality or is         'I-
  misbranded, adulterated or spurious. Section 18 (c) says that
  no person shall himself or by any other person on his behalf
  manufacture for sale or for distribution, or sell or stock or exhibit
  or offer for sale or distribute any-drug or cosmetic, except under,
B and  in accordance with the conditions of, a licence issued for
  such purpose under this Chapter. Section 21 deals with
  Inspectors. The Inspectors can be appointed by the Central
  Government or the State Government by notification in the
  Official Gazette having the prescribed qualifications and they
c may perform such duties for drugs or classes of drugs,or
  cosmetics or classes of cosmetics and they shall be public
  servant within the meaning of Section 21 of the Indian Penal
  Code. Section 22 lays down the powers of the Inspectors. The
  Inspector has power to inspect any premises wherein any drug
  or cosmetic is being manufactured. He has the power for testing
D
  the drugs or cosmetics. He has also power to search and such
  other powers which are necessary for enforcement of the
  provisions of the Act. Section 23 deals with procedure which is
  to be employed by the Inspectors. After taking all necessary
  samples and obtaining report from the Drugs Analyst he can
E also launch prosecution with the previous sanction. Punishment
  has been prescribed under Section 27. Any person who
  manufactures for himself or by any other person on his behalf,
  manufactures for sale or for distribution, or sells or stocks or
  exhibits or offers for sale or distributes any adulterated, spurious
F or misbranded drugs then he shall be punished under Section
  27. Chapter IVA which was introduced with effect from 1.2.1969
                                                                            ~
  deals with provisions relating to Ayurvedic, Siddha and Unani
  drugs. Here also identical provisions are there. Section 33E
  deals with misbranded drugs, Section 33 EE deals with
G adulterated drugs and Section 33EEA deals with spurious drugs
  and it is punishable under Section 33-1. Section 33 G deals with
  the Inspectors which says that the Central Government or a state
  Government may, by notification in the Official Gazette, appoint          ....
  such persons as it thinks fit, having certain prescribed
H qualifications and it has laid down their duties functions 'yVhO.


                                                                                   •
              .
    THE DRUGS INSPECTOR AND ANR. v. MIS. FIZIKEM                  475
    LABORATORIES PVT. LTD. & ANR. [AK. MATHUR, J.]

    could launch prosecution for breach of any of the provisions.        A
           6. The provisions in Chapter IV and Chapter IVA are almost
    identical. Chapter IVA deals with special branch of medicines
    like, Ayurvedic, Siddha and Unani drugs whereas Chapter IV
    deals with branches other than Chapter IVA. Learned Single
    Judge has taken the view that since Ozomen capsules had a            8
    component like sildenafil citrate, therefore, they may be
    misbranded, spurious or adulterated for which the prosecution
    could only be launched by the Inspector authoricsed under
    Chapter IVA. But the prosecution in this case was launched
    under Chapter IV. Therefore, learned Single Judge came to the        C
    conclusion that the Inspector under Chapter IV had no jurisdiction
    to launch the prosecution and it is only the Inspector who has
    been appointed under Chapter IVA could have launched the
    prosecution against the accused for breach of the provisions of
    the Act for adulteration, misbranding in the Ayurvedic drugs.        D
                                '
           7. Learned counsel for the appellants submitted that it is
    not the case that only Chapter IVA is involved but the offence
    has also been committed under Chapter IV also. 'Learned
    counsel for the appellants submitted that Ozomen capsules and
    Ozomen forte had a component of sildenafil citrate and this          E
    medicine does not fall under Chapter IVA. Therefore, learned
    counsel for the appellants submitted that use of this medicine in
    the Ayurvedic medicines is also punishable under Chapter IV
    as accused has no licence to deal with this drug. The accused
    had to mix this drug with other Ayurvedic drugs, therefore, the      F
    accused can also be prosecuted for selling Allopathic drug like
    sildanefil citrate when licence is required under Section 18.
    Learned counsel for the appellants submitted that sildenafil
    citrate is a new drug and it is an Allopathic drug. This cannot be
    used for the Ayurvedic medicines without displaying in the           G
    prescribed manner or. the label or container thereof or list of
)   active ingredients contained in it together with the quantities
    thereof. It is also punishable under Section 18 (a)(iii) read with
    S1::ction 27 (d) of the Act. Learned counsel for the appellants
    also pointed ovt that the respondents also manufactured and          H
    476        SUPREME COURT REPORTS                     [2008] 5 S.C.R.


~   sold this spurious Ozomen capsules containing sildenafil citrate
    violating section 18(a) which is punishable under Section 27(d)
    of the Act. The sum total of the submission of learned counsel
    for the appellants was that the very fact of dealing with sildenafil
    citrate drug and distributing the same after making a different
B   component of Ayurvedic drug itself constitutes an offence.
    Therefore, it is erroneous to say that since the accused is dealing
    with Ayurvedic drugs therefore, only the Inspector who is
    authorized under Chapter IVA could launch the prosecution and
    not the Inspectors appointed under Chapter IV. The accused
C   has used sildenafil citrate which is an allopathic drug. Sildenafil
    citrate is a white to off-white crystalline power with a solubility of
    3.5 mg/ml in water and molecular weight of 666.7 . Viagra
    (sildenafil citrate ) is formulated as blue, film-coated rounded-
    diamond shaped tablets equivalent to 25mg, 50 mg and 100
    mg of sidenafil for oral administration. In addition to the active
0
    ingredient, sildenafil citrate, each tablet contains the following       f

    inactive ingredients; microcrystalline cellulose, anhydrous
    dibasic calcium phosphate, croscarmellose sodium,
    magnesium stearate, hypromellose, titanium dioxide.lactose,
    triacetin and FD & C Blue No.2 aluminum lake. The brand name
E   is Viagra and generic name is sildenafil citrate. This is an
    allopathic drug and by no stretch of imagination it can be said
    as an Ayurvedic drug. Therefore, learned counsel for the
    appellants appears to be justified that since it is an allopathic
    drug and it cannot be used by anybody else unless a person
F   who holds the licence for it. It is an admitted position that the
    accused does not possess the licence. Therefore, the very fact
    of selling this drug as one of the ingredients in the Ozomen
    capsule and not displaying the name in the prescribed manner
    in the drugs will also constitute an offence under Section 18 (a),
G   (b) & (c) punishable under Section 27(b) (ii). The su.bmission of
    learned counsel for the appellants is justified and we are of
    opinion that the view taken by learned Single Judge of the High
    Court is not correct and the High Court should not have
    proceeded to quash the whole proceedings under Section 482
H   of the Code of Criminal Procedure when serious issues were
       THE DRUGS INSPECTOR AND ANR. v. MIS. FIZIKEM                    477
       LABORATORIES PVT. LTD. & ANR. {A.K. MATHUR, J.]

       involved in the matter.                                                A
             8. In the result, we allow this appeal and set aside the order
       passed by the High Court and direct that the Inspector appointed
       under Chapter IV is competent to launch prosecution for the
       aforesaid sections against the accused. We have also been
       informed in the alternative prosecution has also been launched         B
. ->   against the accused under Chapter IVA. Both the prosecution
       can be tagged together and the learned tri;:il court should
       proceed with the matter. However, any observations made by
       us in disposing this appeal will not prejudice the rights of either
       parties.                                                               C

       D.G.                                             Appeal allowed.


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